Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.
This is a randomized controlled pilot study with a study size of 50 patients. Results will be utilized to plan a larger scale study. Background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease SSI although this has not been conducted in this population of patients (lumbar spine fusion) to date. A decrease in SSI with Irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. It will be important to know the effect if any of Irrisept on fusion rates. This study will provide valuable information that may assist in future treatment and prevention of SSI in lumbar spinal fusion patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects v. Normal saline irrigation will be used alone in control subjects at the same time points.
The University of Kansas Medical Center
Kansas City, Kansas, United States
Postoperative surgical site infections
Postop SSI
Time frame: assessed for change at 1 month
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 3 months
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 6 months
Postoperative surgical site infections
postop SSI
Time frame: assessed for change at 12 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed at 1 month
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 3 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 6 months
Fusion rates after surgery
fusion rates after surgery with irrisept vs saline irrigation
Time frame: assessed for change at 12 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
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Time frame: assessed at 1 month
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Visual Analog Score for pain measuring patient outcomes in both study arms
Time frame: assessed at 12 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 1 month
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 12 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 1 month
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 3 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 6 months
Patient outcome measures
Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms
Time frame: assessed at 12 months